02期 总163期 2026年01月03日—2026年01月09日 药渡全球药物研发进展报告 ⸺仿制药篇 加入群聊 联系客服 www.pharmacodia.com 扫码试用 | ★本周渡选★ 2 | | | --- | --- | | 一、 | 国内仿制药研发批准动态 4 | | 首家仿制药品种批准上市情况 4 | 1.1 | | 新注册分类品种批准上市情况 4 | 1.1.1 | | 一致性评价品种批准上市情况 7 | 1.1.2 | | 其他仿制药品种批准上市情况 8 | 1.2 | | 新注册分类品种批准上市情况 8 | 1.2.1 | | 一致性评价品种批准上市情况 16 | 1.2.2 | | 仿制药品种批准临床情况 17 | 1.3 | | 仿制药品种拒绝批准/主动撤回情况 17 | 1.4 | | 二、 | 国内仿制药研发申报动态 18 | | 新注册分类品种申报上市情况 18 | 2.1 | | 一致性评价品种申报上市情况 27 | 2.2 | | 仿制药补充申请情况 28 | 2.3 | | 仿制药申报上市专利声明信息 29 | 2.4 | | 三、 | 国内仿制药研发领域热点聚焦 36 ...

Major Events - CATL (03750) plans to issue an additional 34.8584 million shares [1] - MINIMAX-WP (00100) fully exercised its over-allotment option involving a total of 4.3796 million shares [1] - MIRXES-B (02629) established a strategic partnership with N Health, and its HELICORapid and FITRapid home testing kits received regulatory approval [1] - LFG Investment Holdings (03938) was acquired by Chen Shaoyang, who purchased approximately 61.43% of shares at a discount of about 59.46% through a cash offer, with resumption of trading on January 12 [1] - Xiansheng Pharmaceutical (02096) plans to spin off its H-shares for independent listing on the main board of the Hong Kong Stock Exchange [1] - OmniVision Technologies (00501) saw its public offering in Hong Kong oversubscribed by 9.28 times, with a share price of HKD 104.8 [1] - China Nonferrous Mining (01258) released its production guidance for 2026, expecting a total copper output of approximately 484,000 tons [1] - China Rare Earth Holdings (03788) reported a 53.1% increase in JORC ore reserves to 2.62 million ounces, with JORC gold resources rising to 5.54 million ounces [1] - Black Sesame Intelligence (02533) plans to issue a total of 30.1319 million subscription shares, raising approximately HKD 568 million [1] - Shanghai Pharmaceuticals (02607) received approval for the production of bromhexine oral solution [1] - Beijing Energy International (00686) signed an EPC contract for a 100 MW wind power project in Heilongjiang Province [1] - Standard Chartered Group (02888) plans to issue SGD 750 million fixed-rate reset perpetual subordinated convertible securities [1] Share Buybacks/Reductions - Geely Automobile (00175) repurchased 1.547 million shares for HKD 26.6229 million on January 9 [2] - Sunny Optical Technology (02382) repurchased 840,000 shares for HKD 53.9894 million on January 9 [2] - Xiaomi Group-W (01810) repurchased 4 million shares for HKD 151 million on January 9 [2] Operating Performance - China Jinmao (00817) achieved a cumulative contracted sales amount of RMB 113.5 billion for 2025, a year-on-year increase of 15.52% [2] - Jiumaojiu (09922) reported stable performance for its main brands in the fourth quarter [2] - CIFI Holdings Group (00884) recorded a cumulative contract sales amount of approximately RMB 16.1 billion for 2025 [2] - R&F Properties (02777) reported total sales revenue of approximately RMB 14.21 billion for 2025, a year-on-year increase of 26.54% [2] - Zhongliang Holdings (02772) reported a cumulative contract sales amount of approximately RMB 12.07 billion for 2025, a year-on-year decrease of 32.68% [2] - Shui On Land (00272) achieved a cumulative contract property sales amount of RMB 7.916 billion for 2025 [2] Additional Performance Metrics - Greenland Hong Kong (00337) reported contract sales of approximately RMB 7.214 billion for 2025, a year-on-year decrease of 21.66% [3] - Yuzhou Group (01628) achieved a cumulative sales amount of RMB 6.727 billion for 2025 [3] - New World Development (01030) reported contract sales of approximately RMB 1.354 billion in December [3] - China Shipbuilding Defense (00317) expects a year-on-year increase of 149.61% to 196.88% in net profit attributable to shareholders for 2025 [3] - Longyuan Power (00916) completed a cumulative power generation of 76.4694 million MWh for 2025, a year-on-year increase of 1.22% [3] - Sunny Optical Technology (02382) reported a December shipment of 95.592 million mobile phone lenses, a year-on-year decrease of 8.9% [3] - COFCO Joycome (01610) reported a December pig output of 567,000 heads, a month-on-month increase of 1.43% [3] - Dekang Agriculture (02419) sold 1.1097 million pigs in December, generating sales revenue of RMB 1.664 billion [3] - Hengding Industrial (01393) reported a coal output of 5.415 million tons for 2025, a year-on-year increase of 31% [3] - Orient Overseas International (00316) reported a 17.2% decrease in quarterly shipping revenue compared to the same period last year, with total cargo volume up 0.8% and carrying capacity up 4.5% [3]

Group 1 - China Shipbuilding Defense expects a net profit of 940 million to 1.12 billion yuan for 2025, an increase of 149.61% to 196.88% year-on-year [1] - China First Heavy Industries has only undertaken a small number of related accessory projects and has not generated revenue from them [2] - Huanyu Electronics plans to invest 30 million yuan in a private equity fund focused on AI and emerging industries [3] Group 2 - Zhixiang Jintai's GR1803 injection has been included in the priority review list by the National Medical Products Administration [4] - JianKai Technology's shareholder plans to reduce holdings by up to 3% of the company's shares [5] - Debon Holdings will continue to suspend trading from January 12 due to significant matters being planned [6] Group 3 - South Network Technology's shareholder intends to transfer 847.05 million shares, accounting for 1.50% of the total share capital [7] - Hengrui Medicine has received approval for clinical trials of four drugs [8] - Daotong Technology expects a net profit of 900 million to 930 million yuan for 2025, a year-on-year increase of 40.42% to 45.10% [10] Group 4 - Betta Pharmaceuticals has invested 50 million yuan to acquire a 20% stake in Hangzhou Zhixing Pharmaceutical [11] - Tianyu Biology reported a 10.38% year-on-year decline in cumulative sales revenue for 2025 [12] - Lifang Pharmaceutical's subsidiary has obtained a drug registration certificate for a pain relief product [13] Group 5 - R&F Properties reported a total sales revenue of approximately 14.21 billion yuan for 2025 [14] - Wanfu Biology expects a net profit decline of 87.71% to 91.81% for 2025 [15] - Dazhi expects a negative net profit for 2025 [16] Group 6 - Dongzhu Ecology is negotiating to terminate the acquisition of control over a satellite communication company [17] - Baotai has received a milestone payment of 10 million USD from Hikma Pharmaceuticals [18] - Huace Navigation expects a net profit of 670 million to 690 million yuan for 2025, a year-on-year increase of 14.84% to 18.27% [19] Group 7 - Shenzhen Gas reported a net profit decline of 3.45% for 2025 [20] - Baogang Co. plans to adjust the price of rare earth concentrate for Q1 2026 to 26,834 yuan per ton [21] - Jiuding Investment expects to report a loss for 2025 [22] Group 8 - Shanghai Pharmaceuticals has received a drug registration certificate for a treatment for myasthenia gravis [23] - Hualan Biological plans to acquire a 35% stake in Guangfeng Capsule [24] - Ruina Intelligent plans to invest 169.9 million yuan in a new R&D production base for heat pumps [25] Group 9 - Wantong Development expects to report a loss for 2025 [26] - Xianghe Industrial has completed the purchase of a 5% stake in Hezhixiang Technology [27] - Guangkang Biochemical received a warning letter from the Guangdong Securities Regulatory Commission [28] Group 10 - Xiaoming Co. reported a 37.07% year-on-year decline in chicken product sales revenue for December 2025 [29] - Luokai Co. won a procurement project from State Grid Fujian Power worth approximately 48.2 million yuan [30] - Minhe Co. reported a 65.22% year-on-year increase in the sales of commodity chick seedlings for December 2025 [31] Group 11 - Zhenghai Biological has obtained a registration certificate for calcium silicate bio-ceramic materials [32] - Three Gorges Energy reported a 5.99% year-on-year increase in cumulative total power generation for 2025 [33] - Huisheng Biological expects a net profit of 235 million to 271 million yuan for 2025 [34] Group 12 - Maihe Co. announced the release of the detention measures against its chairman [35] - Wandong's Alzheimer's project has been included in a national major special project for innovative drug development [36] - Kangxin New Materials plans to transfer forest land assets with a book value of 1.203 billion yuan [37] Group 13 - Greenland Holdings expects a net loss of 16 billion to 19 billion yuan for 2025 [39] - Zhongxin Fluorine Materials has obtained a pesticide production license [40]

Core Viewpoint - Shanghai Pharmaceuticals has received approval from the National Medical Products Administration for the production of Bromides of Pyridostigmine oral solution, which is used to treat myasthenia gravis [1] Company Summary - Shanghai Pharmaceuticals announced that its subsidiary, Shanghai Shiyou Zhongxi Pharmaceutical Co., Ltd., has been granted a drug registration certificate for Bromides of Pyridostigmine oral solution [1] - The drug was first launched in the United States in 1965, indicating a long history of use in the treatment of myasthenia gravis [1]

Core Viewpoint - Shanghai Pharmaceuticals has received approval from the National Medical Products Administration for the production of Bromides of the oral solution, which is used to treat myasthenia gravis, marking a significant milestone for the company in expanding its product portfolio in the pharmaceutical market [1] Group 1: Product Approval - The oral solution of Bromides has been granted a drug registration certificate (Certificate No: 2025S04074) by the National Medical Products Administration [1] - The product was originally developed by BAUSCH and was first launched in the United States in 1965 [1] - Shanghai Pharmaceuticals submitted the registration application for this product in April 2024, which has been accepted by the regulatory authority [1] Group 2: Financial Investment - The company has invested approximately RMB 2.3174 million in research and development for this product as of the date of the announcement [1] - There are currently no other companies in China that have this product listed for sale [1] Group 3: Market Potential - According to the IQVIA database, the procurement amount for Bromides tablets in hospitals in mainland China is RMB 60.29 million for the year 2024 [1]

Core Viewpoint - Shanghai Pharmaceuticals has received approval from the National Medical Products Administration for the production of bromhexine oral solution, indicating a significant advancement in its product portfolio [1] Group 1 - Shanghai Pharmaceuticals Group Co., Ltd. announced that its subsidiary, Shanghai Shiyou Chinese-Western Medicine Co., Ltd., has obtained a drug registration certificate for bromhexine oral solution [1] - The drug registration certificate number is 2025S04074, confirming the approval for production [1]

Core Viewpoint - Shanghai Pharmaceuticals (601607.SH) announced that its subsidiary, Shanghai Shiyou Zhongxi Pharmaceutical Co., Ltd., received a drug registration certificate from the National Medical Products Administration for its oral solution of Pyridostigmine Bromide, which is approved for production [1] Group 1 - The oral solution of Pyridostigmine Bromide is used for the treatment of myasthenia gravis and was originally developed by BAUSCH, first launched in the United States in 1965 [1] - Shanghai Shiyou submitted the registration application for this drug to the National Medical Products Administration in April 2024, which has been accepted [1] - As of the announcement date, the company has invested approximately RMB 2.3174 million in research and development for this drug [1] Group 2 - There are currently no other companies in China that have this drug listed for sale [1]

Group 1 - The core point of the article is that Shanghai Pharmaceuticals has received approval from the National Medical Products Administration for the production of Bromides of the Ming oral solution, which is used to treat myasthenia gravis [1] - The drug was originally developed by BAUSCH and was first launched in the United States in 1965 [1] - As of the announcement date, the company has invested approximately 2.3174 million yuan in the research and development of this drug [1] Group 2 - There are currently no other companies in China that have this drug listed for sale [1]

Core Viewpoint - Shanghai Pharmaceuticals' subsidiary, Shanghai Shiyou Zhongxi Pharmaceutical Co., Ltd., has received a drug registration certificate from the National Medical Products Administration for Bromides of the Ming oral solution, which is approved for production and is used to treat myasthenia gravis [1] Group 1 - The drug Bromides of the Ming oral solution was originally developed by BAUSCH and was first launched in the United States in 1965 [1]